Characterization of buffy-coat-derived granulocytes for clinical use: - identifying clinical and laboratory parameters for decision making
Recruiting
- Conditions
- infectionsneutropenic fever10018849
- Registration Number
- NL-OMON50313
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
• 18 years or older
• Admitted to the adult haematology department of the AMC
• Diagnosed with a hematological malignancy and receiving high dose
chemotherapy, undergoing myeloablative treatment prior to allogeneic HSCT or
having intensified immunosuppression due to graft-versus-host disease.
• Able and willing to provide written and dated informed consent prior to any
study specific procedure
Exclusion Criteria
• Patients unable to give written and dated informed consent
• Patients younger than 18 years
• Patients who had granulocyte transfusions before inclusion
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>• Identification of biomarkers indicating (the course of) neutropenia and<br /><br>neutropenic fever.<br /><br>• A predictive model from laboratory and clinical markers in order to predict<br /><br>the cause of the neutropenic fever.<br /><br>• A model based on the established biomarkers to identify patients suitable for<br /><br>GTX and to determine the individual risk for complications during GTX.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>